Diphenhydramine Hcl 25 Mg Capsules

Diphenhydramine Hcl 25 Mg Capsules
SPL v6
SPL
SPL Set ID 32fa40ad-fed5-586f-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2015-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
D&c Red No. 28 Methylparaben Sodium Lauryl Sulfate Gelatin Polysorbate 80 Propylparaben Benzyl Alcohol Butylparaben Fd&c Blue No. 1 Fd&c Red No. 40 Lactose Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: AP;20 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-01
Description

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCL 25 mg

Uses

temporarily releaves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes
Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS BROKEN OR MISSING

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Section 50568-5

Ask a doctor or pharamcist before use if you are taking sedatives or tranquilizers

Drug Facts continued of back of label

Section 50569-3

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Section 51945-4

NDC 69618-024-01

Diphenhydramine HCL 25 mg

ANTIHISTAMINE

100 CAPSULES

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Do not use

  • with any otherprodcut containing diphenhydramine, even one use on skin
  • to make a child sleepy
Directions
  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over

1 to 2 capsules
children 6 to under 12 years

1 capsule
children under 6 years do not use

Other Information
  • store at room temperature
  • protect from moisture
Inactive Ingredients

benzl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methlyparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions Or Comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Capsule)

Diphenhydramine HCL 25 mg

Structured Label Content

Uses

temporarily releaves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes
Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS BROKEN OR MISSING

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Section 50568-5 (50568-5)

Ask a doctor or pharamcist before use if you are taking sedatives or tranquilizers

Drug Facts continued of back of label

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Section 51945-4 (51945-4)

NDC 69618-024-01

Diphenhydramine HCL 25 mg

ANTIHISTAMINE

100 CAPSULES

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

Warnings

Do not use

  • with any otherprodcut containing diphenhydramine, even one use on skin
  • to make a child sleepy
Directions
  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over

1 to 2 capsules
children 6 to under 12 years

1 capsule
children under 6 years do not use

Other Information (Other information)
  • store at room temperature
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

benzl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methlyparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCL 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.063978 · Updated: 2026-03-14T23:07:03.829205